The Phase I Study of SIG001 Antibody on Cancer Therapy.

Summary

The goal of this clinical trial is to learn the safty characteristics of SIG001 Mab in cancer patients; It will also determine the Recommended Phase II dose of SIG001 Mab on cancer treatment, and pharmacological characteristics of SIG001. The main questions it aims to answer are:

What is the safety and tolerability of SIG001 in patients with advanced solid tumors ? What is the Recommended Phase II dose of SIG001? What is the PK/PD characteristics of SIG001 in cancer patients? What is the antitumor activity of SIG001 in cancer patients? What is the immunogenicity of SIG001 in cancer patients? What is the relationship between the exposure/dose of SIG001 and its safety as well as clinical efficacy? What is the expression levels of potential biomarkers (such as SIG), if applicable, and analyze their correlation with drug exposure, efficacy, and safety? What is event-related endpoints such as the Duration of Response and Progression-Free Survival in patients treated with SIG001?

This will be a single-armed study.

Participants will:

Intravenously Inject SIG001 every two weeks, for 4 weeks Visit the clinic on the 14th day, 30th day, and 90th day afer the last injection. Then visit the clinic for every 12 weeks.

Conditions

• Neoplams

Interventions

BIOLOGICAL

SIG001

Intravenous administration. The dose-escalation study was conducted using a BOIN design. The starting dose in the escalation regimen was 0.15 mg/kg Q2W. The dose increases were at rates of 167%, 150%, 80%, 94.4%, and 71.4%, respectively, until a dose of 6 mg/kg was reached.

BIOLOGICAL

SIG001

At least 2 dosage levels will be selected for intravenous administration based on the safety and efficacy data from the dose-escalation studies.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Guangzhou SIG Biomedical Technology Co., Ltd.

  collaborator UNKNOWN

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Peking University

  lead OTHER

Principal Investigators

• Lin Shen, Doctor · Peking University Cancer Hospital & Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2028-04-30

Completion

2028-07-31

Countries

• China

Study Locations